Day

October 12, 2012
12
Oct

GAO report on FDA review ofmedical device security

October 12, 2012
/Docs/scpred/standardsnavigator/GAO_FDA_security_report.pdf
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12
Oct

FCC Report on Mobile Health

October 12, 2012
An FCC mHealth task force reported recommendations to government and industry to address barriers to rapid mHealth deployment. See the link provided: FCC 2012 Mhealth Taskforce Recommendations.
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12
Oct

EU proposed new Medical Device Directive

October 12, 2012
Draft of the revised MDD is at the link provided. The existing Active Implantable Device Directive is incorporated into the new MDD. EU Proposed New MDD
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12
Oct

EU proposed new In Vitro Device Directive

October 12, 2012
Draft of the revised IVDD is at the link provided. EU Proposed New IVD
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12
Oct

AAMI/UL collaboration on interoperability standard

October 12, 2012
See the attached press release from AAMI and UL regarding their collaboration to produce a series of interoperability standards. AAMI UL Interoperability Press Release
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12
Oct

AAMI/FDA Interoperability Summit presentations

October 12, 2012
Presentations made at the AAMI/FDA Interoperability Summit on October 1-2, 2012, can be found at the link provided. http://www.aami.org/interoperability/presentations
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SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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